Challenges in development and management of orphan drugs—a case study of Prussian blue insoluble

Abstract

Abstract Prussian blue insoluble (PB) is an antidote for decorporation of radioactive and non-radioactive isotopes of thallium and cesium. Its dosage in the form of capsules, Radiogardase-Cs, is a United States Food and Drug Administration approved formulation since 2003. In India and many other countries, this drug is not available and in case of requirement it is imported from US or Europe. The author has worked extensively to make PB capsules available in India. The drug was recently approved by the Indian drug regulatory agency, Central Drugs Standard Control Organisation and is now available commercially in India. However this drug needs special attention as it is an orphan drug with limited requirement. The post-approval phase of this drug poses a different set of challenges and the author has highlighted some key issues with probable approaches for post-approval product management.